Objective: To evaluate the efficacy of single doses of intravenous diclofenac sodium (25, 50 and 75 mg) in patients with post-operative pain after third-molar surgery in a randomised, placebo-controlled study.

Methods: Two hundred and sixty-nine patients (168 females) who required the removal of their impacted third molars participated in the study, which had received prior ethical approval. Surgery was completed under general anaesthesia and, during the early post-operative period, patients received either a single intravenous dose of diclofenac (25, 50 or 75 mg) or matched placebo in random, double-blind order. Pain intensity was assessed on 10-cm visual analogue scales at fixed time points throughout a 4-h investigation period. Other efficacy variables obtained included time until rescue medication and overall assessment at 4, 6, 12 and 24 h after dosing.

Results: Throughout the 4-h investigation period, patients treated with diclofenac reported significantly less pain than those treated with placebo (P < 0.001). No differences were observed among the three doses of diclofenac (P = 0.22). Similar results were observed at 6, 12 and 24 h after dosing. Significant differences were also noted between the placebo group and all the diclofenac treatment groups with respect to time until rescue medication (P < 0.001) and the proportion of patients taking such medication.

Conclusion: Single doses of i.v. diclofenac (25, 50 and 75 mg) provide significant pain relief after third-molar surgery. The efficacy of this preparation does not appear to be dose related.

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http://dx.doi.org/10.1007/s002280000177DOI Listing

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